Monthly Archives: November 2013

Today the FDA dropped a big m-fing hammer on 23andme, a service that will allow you some insight into your own genome. They offer, along with the ability to get a raw report about the specific genes they track, some level of analysis of your genome. They can use your data to look for specific known genetic markers of inherited conditions, and giving you advance warning that you may be at elevated risk of certain problems. In addition, by trying to build a large database of genetic data, they are vastly accelerating the degree to which future genetic markers can be understood for analysis.

This, according to the FDA, is data used for diagnostic and prevention purposes, and therefore makes 23andme a “Medical Device”. Suffice to say that medical devices must to be FDA approved, according to the law, and 23andme hasn’t completed all the hoops necessary to allow me to spit in a cup and send it to a lab. So they can’t sell their kits any longer.

This puts some people, like my wife and myself, in a bit of a strange position.

As many of you know, our 4yo son is autistic. We’ve been through quite a bit to potentially understand the causes of his autism. Without getting too deep into the matter (there are many possible causes, each with its own camp of die-hard adherent believers, all of whom hate each other*), one of the avenues we’ve been traveling down is testing for various types of biomedical dysregulation. As a result, we’ve found that he has a genetic mutation common in a lot of autistic individuals related to what is called the “methylation pathway”. This is a biologic process related to brain activity and development, so the fact that it’s short-circuited gives some indication of where things can be helped**.

So my wife and I are taking this as a chance to better understand more about our own genetic profiles, and with the added benefit of determining more clearly where my son’s genetic mutations have come from***. So we both did the “spit in a tube” thing last week, and our samples are happily on their way to 23andme.

Now, I’m smart enough to know that genetics is NOT an exact science. That getting a report that there might be elevated risk for X doesn’t mean I have X****. I’m not going to use the information to make rash decisions about my medical care.

But it’s a start. It’s information that I don’t have today. It’s information that may be of immeasurable benefit to me in the near term and down the road, if it reveals something real. And it’s information that the FDA doesn’t trust me to have.

“Trust” is the term there. The FDA doesn’t trust us mere citizens. It doesn’t believe we’re capable of making decisions that affect our very lives. The 23andme genetic information isn’t perfect, but they believe that if we can’t get perfect information, we’re better off with no information. This information, of course, is getting better. One of the possible advantages of a widening circle of people partaking in 23andme research is that they can improve their ability to analyze a sample, looking for correlations years from now based on the sample I just gave. Part of the reason I wanted to do this was based upon expected future benefit in addition to learning about the aspects of my genetic that already relate to known markers.

So, our saliva is on the way. With the FDA’s recent proclamation, does that mean that 23andme will complete the testing on our samples? Or will the brakes be put on before they’re allowed to run the test? Will this action end up killing the company, so that even if I *do* get my results today there will never be any future research to make the findings more valuable to me?

So thanks a lot, FDA. You’re making me wonder if I’ll ever get the information I absolutely want and paid for. You’re making the future value of that investment lower, by putting into question the future of 23andme and the amount of data they have access to to analyze. And by doing so, you’re probably putting the brakes on the speed at which future genetic breakthroughs will manifest by artificially culling the data set. Nobody will know how many people will die in the future as a result of slower progress in the growing field of genetic research, but they won’t thank you, nor will I, for protecting me from this information today.

The following, unbelievable story is happening in America of all places!

DEARBORN, MI This past fall, Emily Sanders enrolled her son Adam into Haigh Elementary School in Dearborn. Emily a devout Evangelical Christian is a single mom trying to make ends meet and faces additional challenges as a minority in a majority Muslim community. “I don’t normally let these kinds of [religious] differences bother me,” Emily said. “But when my child brought home a note from the school requesting a donation to a Muslim charity with an agenda to spread their faith with my tax dollars, I had to take a stand.”

The letter Emily is referring to one sent to all the parents from the school’s principal, George Ellis. Part of the letter read: “We are very proud to be part of this charity that provides hope to poor children of Somalia. Please send a care package (shoe boxes work great!) filled with toys, candy, coloring books, crayons, and other such goods along with a $7 check (to cover shipping) made out to Crescent Hope. We will be collecting these donations, Friday, December 5th during Eid al-Adha.”

Emily, being unaware of the Islamic holiday Eid al-Adha and the charity Crescent Hope at first shrugged it off. “Sending toys and candy to poor children sounds like a great thing at first glance but when I saw that there was more to this charity than this, the alarm bells started going off.”

The alarm bells were triggered primarily from a key section of text on Crescent Hope’s home page: “We provide spiritual and physical aid to the children of Somalia with the purpose of sharing the Prophet Muhammad’s message of hope and peace.” Further down on the home page reads: “[T]he children receive the packages, each complete with a pledge they are encouraged to sign that states that they agree to the statement: ‘There is no god but Allah and Muhammad is his prophet.’”

Upon reading this, Emily decided to take action by contacting the American Center for Law and Justice (ACLJ), a religious rights advocacy organization which primarily files lawsuits on behalf of Christians who have been victims of religious discrimination. The very next day, Emily was contacted by the ACLJ’s Chief Council Jay Sekulow. After about an hour long conversation with Emily, Sekulow promised to take action against the school.

On Wednesday, November 20th, Sekulow made good on this promise sending the school’s principal a cease and desist letter. After mulling over his options, Principal Ellis announced to the school children that the packages would be returned to the students and no other donations would be accepted adding: “It’s disappointing some meaningful efforts of our students were misinterpreted.”

Manahil Al-Asmari, mother of three students who attend Haigh Elementary had a typical response of many of the parents: “I don’t understand why the ACLJ wants to deny these gifts to these poor children. I mean the school wasn’t forcing any of the students to participate who didn’t want to participate.” Another mother who didn’t want to be named said: “This is discrimination against Muslims pure and simple! If this was for a Christmas toy drive, no one would bat an eye.” Her son agreed adding “This is the definition of bullying.”

Others such as the Dearborn Chapter President of CAIR, Aahil Muhammad is organizing a protest against the school’s decision. “Whether the Christians like it or not, this is a majority Muslim community and they are the minority. We shouldn’t be denied our religious freedom because the minority is offended by our beliefs. I should also point out that it was the student body who decided to support Crescent Hope and the administration supported that decision – at least until ACLJ came along.”

Outrageous isn’t it? The idea taxpayer funded government schools can be used as a vehicle to promote a religious agenda different than your own? Before you continue reading, think about what you are feeling at this moment. Is this right or should Emily have just respected the will of her community?» Read more